Medical Device Design Validation SOP

Quick Overview

This Standard Operating Procedure (SOP) describes the program necessary to validate the design of COMPANY products against User Requirements. This Standard Operating Procedure (SOP) describes the This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP.

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General

This SOP applies to all medical devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such medical devices. This Design Controls SOP does not apply to medical devices in very early stage of development such as early concept or feasibility stages. Design Controls begin after concept and feasibility studies are completed after the COMPANY Management approves the initiation of a Product Development Project.

This SOP does not describe the validation process for Product Software or clinical testing.